Early this morning, the Wall Street Journal
published an investigative reportthat
said former Theranos employees claimed the
company was not using their own new "revolutionary" blood tests
for the majority of lab testing, largely because of concerns
about accuracy.

In response, the company says that the Journal relied on sources
who were not in a position to know whether the tests were
accurate or not, and called the doubts about accuracy "baseless"
and "erroneous."

Today’s Wall Street Journal story about Theranos is factually and
scientifically erroneous and grounded in baseless assertions by
inexperienced and disgruntled former employees and industry
incumbents. Theranos presented the facts to this reporter to
prove the accuracy and reliability of its tests and to directly
refute these false allegations, including through over 1,000
pages of statements and documents. Disappointingly, the Journal
chose to publish this article without even mentioning the facts
Theranos shared that disproved the many falsehoods in the
article.

Theranos’ products and services have proven accurate and reliable
for tens of thousands of satisfied customers through millions of
tests and experiences and in ongoing review by our various
regulators. Our focus remains ensuring high quality real-time,
actionable information to improve diagnosis and treatment
decisions. When you create innovative technology, scrutiny is to
be expected. We have always welcomed that scrutiny – opening up
to regulators like no lab before and voluntarily submitting all
our tests for FDA review, the gold-standard for quality. We
received our first FDA clearance this summer based on the very
proprietary systems the story is asserting don’t work, and have
submitted almost 130 pre-submissions at FDA for tests run on
those proprietary systems.

Theranos is working to reinvent the lab experience by providing
high quality tests faster, cheaper, and more conveniently,
requiring less blood, and causing less patient discomfort than
ever before. We lead the industry in transparency and quality,
have advocated for FDA regulation of lab tests, for the reduction
of Medicare and Medicaid rates, and for transparency in pricing.
We’ve partnered with health care leaders including the Cleveland
Clinic, Capital BlueCross and AmeriHealth Caritas. We also have
advocated for direct access to lab testing, which will drive
price transparency and lower the cost of testing in response to
consumer demand; this issue is at the heart of the current
movement towards individual engagement and preventive health
care.

The sources relied on in the article today were never in a
position to understand Theranos’ technology and know nothing
about the processes currently employed by the company. We are
disappointed that, in an effort to make its story more dramatic,
this reporter relied only on the views of four “anonymous”
disgruntled former employees, competitors and their allies,
instead of reaching out to many of the scientific, health care
and business leaders who have actually seen, tested, used and
examined our breakthrough technologies. The Journal even declined
an opportunity to experience the technology themselves by turning
down our offer to send proprietary Theranos devices to their
offices so they could have a demonstration of tests conducted
themselves, and compare the results to those of other testing
providers.

Stories like this come along when you threaten to change things,
seeded by entrenched interests that will do anything to prevent
change, but in the end nothing will deter us from making our
tests the best and of the highest integrity for the people we
serve, and continuing to fight for transformative change in
health care.